News
28.09.2021 - Cosmetics
Burkholderia cepacia complex in non-sterile pharmaceuticals
A recent letter from the FDA in the USA warns about the contamination risk of non-sterile drugs with microorganisms from the Burkholderia cepacia complex (BCC). The BCC currently includes more than 20 species of gram-negative bacteria that can cause diseases in humans as opportunistic pathogens. Several recalls of contaminated drugs with these microorganisms have already been published. Specifically, the FDA recommends manufacturers, among others:
- Prevent contamination by using suitable materials and equipment as well as adequate hygiene measures
- Select and control a water system that prevents the formation of biofilms
- Conduct an appropriate hazard and risk analysis regarding potential microbiological risk
- Comply with microbiological product specifications
- Implement appropriate corrective actions in the event of abnormalities
The BAV Institute tests drugs for the presence of BCC using the procedure of the US Pharmacopeia (USP), Method USP 60. Have your products regularly tested microbiologically; our institute tests according to all described procedures of the European Pharmacopeia (Ph.Eur.) as well as the USP.
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